| Trial registration number
|
EUCTR2020-001794-77-ES |
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001794-77/ES
|
First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Catalan Institute of Oncology - Clinical Research Unit
|
Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
bmartin@iconcologia.net
|
Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
2020-07-22
|
Recruitment status
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Recruiting
|
Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
RCT
|
Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Randomized
|
Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Parallel
|
Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Open label
|
Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
multi-center
|
Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Treatment
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Personal history of active cancer.
Confirmed COVID19 current infection
Age ≥18 years
ECOG Performance Status ≤2
Historial de cáncer activo
Infección por COVID19 confirmada
Edad ≥18 años
ECOG Performance Status ≤2
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Not possibility of receiving oral drugs
Hemodinamic inestability
Patients requiring non invasive ventilation or FIO2> 50%
Patient with a cancer survival prognosis <3 months for its oncologic disease.
Imposibilidad de recibir tratamiento oral
Inestabilidad hemodinámica
Pacientes con requerimientos de O2 elevados (FIO2> 50%) o de ventilación no invasiva
Pacientes con esperanza de vida debido a su enfermedad oncológica estimada inferior a 3 meses
|
Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
2
|
Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
INSTITUT CATALÀ D'ONCOLOGIA GIRONA - HOSPITAL JOSEP TRUETA
|
Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
100
|
Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Spain
|
Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Mild disease at enrollment
|
Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
1: Mild disease at enrollment
|
Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
92
|
primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Proportion of patients requiring mechanical ventilation
Proporción de pacientes que requieren ventilación mecánica
|
Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Declared number of arm (2.0)
differs from found arms (1.0)
|
Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
Phase 2
|
Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
|
[{"arm_notes": "", "treatment_id": 1196, "treatment_name": "Silibinin", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|